Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies With Early Access Authorization in Immunocompromised Patients. A Prospective Cohort. (PRECOVIM)

This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Immunocompromised Host

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Vincent LEVY, MD, PhD; Phone Number: +33 1 48 95 77 33; Email: vincent.levy@aphp.fr
• Study Contact Backup: Name: Guillaume Martin-Blondel, MD, PhD; Email: martin-blondel.g@chu-toulouse.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Recruiting
    • Hôpital Avicenne
    • Contact: Vincent LEVY, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who may be included in the cohort are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) or full market approval. In case of ATUc, patient are treated and monitored according to the Therapeutic Use Protocols specific for each ATU treatment defined by the ANSM.

In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.

Description

Inclusion Criteria:

• Adults (18 years-old or more)
• Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations
• qPCR negative at baseline
• SARS-CoV-2 RT-qPCR Negative at inclusion
• Patients who remain seronegative after a complete COVID-19 vaccination schedule
• Immunocompromised patients :

Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor

• Life expectancy > 3 months
• Social security affiliation
• Lack of a legal protection measure
• Signed informed consent

Exclusion Criteria:

• Participation to another clinical study
• State medical aid
• Ongoing or scheduled plasmapheresis or immunoadsorption
• Pregnant / lactating woman
• Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection
• Hypersensitivity to one of the active substances or to one of the excipients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EVUSHELD (tixagévimab/cilgavimab) 300 mg; Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 300mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.
EVUSHELD (tixagévimab/cilgavimab) 600 mg; Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 600mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neutralizing antibody activity	Month 1
Neutralizing antibody activity	Month 2
Neutralizing antibody activity	Month 3
Neutralizing antibody activity	Month 4
Neutralizing antibody activity	Month 5
Neutralizing antibody activity	Month 6
Neutralizing antibody activity	Month 9
Neutralizing antibody activity	Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection	Month 12
Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period	Month 12
Proportion of patients infected with a resistant variant	Month 12
Proportion of patients with treatment AE	Month 12
Severity of treatment AE	Month 12
Proportion of patients with SAE	Month 12
Proportion of patients with suspended prophylaxis due to adverse event	Month 12
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 1
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 2
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 3
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 4
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 5
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 6
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 9
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 12
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 1
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 2
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 3
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 4
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 5
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 6
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 9
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 12
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 1
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 2
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 3
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 4
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 5
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 6
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 9
Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2	Month 12
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 1
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 2
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 3
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 4
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 5
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 6
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 9
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 12
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 1
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 2
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 3
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 4
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 5
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 6
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 9
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 12
Anti-S et Anti- N antibodies levels	Month 1
Anti-S et Anti- N antibodies levels	Month 2
Anti-S et Anti- N antibodies levels	Month 3
Anti-S et Anti- N antibodies levels	Month 4
Anti-S et Anti- N antibodies levels	Month 5
Anti-S et Anti- N antibodies levels	Month 6
Anti-S et Anti- N antibodies levels	Month 9
Anti-S et Anti- N antibodies levels	Month 12

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Principal Investigator: Vincent LEVY, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• de Lamballerie X, Martin-Blondel G, Dupont A, Izopet J, Mentre F, Kamar N, Autran B, Paintaud G, Caillard S, le Bourgeois A, Richez C, Couzi L, Xhaard A, Marjanovic Z, Avouac J, Jacquet C, Anglicheau D, Cheminant M, Yazdanpanah Y, Guyen SN, Terrier B, Gottenberg JE, Besson C, Letrou S, Kali S, Angoulvant D, Sanchez VP, Tardivon C, Blancho G, Levy V. Low serum neutralization of Omicron variants a month after AZD7442 prophylaxis initiation. J Infect. 2022 Oct 8:S0163-4453(22)00565-5. doi: 10.1016/j.jinf.2022.10.006. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Anticipated): June 26, 2024
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Post-Exposure Prophylaxis; Antibodies Monoclonal; Neutralizing Antibodies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ANRS0166s; 2021-006961-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No